# E2 - Endovascular Engineering

> E2, formally Endovascular Engineering, is a Menlo Park medical-device company developing Hēlo, a catheter system for removing pulmonary and venous clots. Its expandable funnel combines a compact crossing profile with a larger clot-engagement opening; a separate blood-return system addresses blood lost during aspiration. Hēlo received FDA 510(k) clearance in December 2025, and E2 raised an $80 million Series C in April 2026.

- **Founded:** 2019
- **Headquarters:** Menlo Park, United States
- **Founders:** Luis Savastano (Founder and Chief Scientific Officer), Mike Rosenthal (Co-founder and Chief Operating Officer)
- **Products:** Hēlo Thrombectomy System, Hēlo Blood Return System
- **Notable:** FDA 510(k) clearance for Hēlo Thrombectomy System on December 18, 2025 (K252956)., First-in-human ENGULF feasibility cohort of 25 patients published in JSCAI in 2024., ENGULF pivotal cohort enrolled 105 patients at 19 U.S. hospitals and met prespecified safety and efficacy endpoints.

## Products & services

- **Hēlo Thrombectomy System** — FDA-cleared, single-use catheter system for non-surgical removal of emboli and thrombi from pulmonary arteries and peripheral veins; uses an expandable funnel, aspiration and mechanical agitation.
- **Hēlo Blood Return System** — Investigational adjunct that filters and returns a patient's aspirated blood during thrombectomy; studied in ENGULF.

## Achievements

- FDA 510(k) clearance for Hēlo Thrombectomy System on December 18, 2025 (K252956).
- First-in-human ENGULF feasibility cohort of 25 patients published in JSCAI in 2024.
- ENGULF pivotal cohort enrolled 105 patients at 19 U.S. hospitals and met prespecified safety and efficacy endpoints.
- Raised $80 million Series C in April 2026, bringing the three announced rounds to $137 million.
- 2026 SCAI analysis reported median procedural blood loss of 10 mL with blood return versus 340 mL without in nonrandomized cohorts.

## Latest updates

- **2026-04** — Raised $80 million Series C, co-led by Gilde Healthcare and Norwest, for Hēlo commercialization.
- **2026-04** — SCAI reported an ENGULF analysis of 40 blood-return and 90 non-blood-return patients; median blood loss was 10 mL versus 340 mL.
- **2026-04** — AngioDynamics filed a patent infringement complaint against E2 concerning Hēlo's funnel features; allegations remain allegations.
- **2025-12** — FDA cleared Hēlo Thrombectomy System under 510(k) K252956.

## Links

- Website: https://endovascularengineering.com/
- LinkedIn: https://www.linkedin.com/company/endovascular-engineering/

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Profile page: https://yespress.io/e2
Published by YesPress — https://yespress.io
Last updated: 2026-09-29